It is India’s first mRNA based Omicron-specific booster vaccine. It will be available under the name GEMCOVAC-OM.
The Drugs Controller General of India (DCGI) has approved the country’s first mRNA-based Omicron-specific booster vaccine, which is developed by Gennova Biopharmaceuticals Ltd, for emergency use. The Pune-based company on Tuesday released a press release to announce that its vaccine against the Omicron variant of SARS-CoV-2, which will be available under the name GEMCOVAC-OM, has received Emergency Use Authorization (EUA) from the office of the DCGI.
According to Gennova, GEMCOVAC-OM is the first booster COVID-19 vaccine developed in India against the highly transmissible Omicron variant. Approximately 3000 individuals received the vaccine in the Phase-II/ III trials clinical trial conducted at 20 centers across 13 cities in India. The vaccine was found safe, well tolerated as well as demonstrated robust immune responses.
Why do we need Omicron-Specific Booster Vaccine?
COVID-19 vaccines that are currently used as precautionary/booster doses in India are designed to fight against the ancestral strain of SARS-CoV-2. These existing vaccines may increase the antibody titers, but they may not be effective against the circulating Omicron variant of SARS-CoV-2. Hence the need to develop antibodies and memory immune responses specific to the Omicron variant to reduce the probability of infection and hospitalization as well as prevent future waves of the COVID-19 pandemic. The development of GEMCOVAC-OM specifically addresses this gap, the company stated.
Know more about GEMCOVAC-OM
According to the developer, it is a lyophilized (freeze dried) vaccine, stable at 2- 8 C, and can be delivered intradermally using a needle-free device. Developed by the USA-based company PharmaJet, the device called Tropis, does away the disadvantages of using a needle, such as a needle phobia, sharps disposal, and needle-stick injuries.
Adults of 18 years of age and older, who have received two doses of either COVAXIN or COVISHIELD, can take the vaccine as booster dose.
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Dr. Sanjay Singh, CEO, Gennova Biopharmaceuticals Limited, noted that COVID-19 will remain and keep mutating, and therefore it is important to have vaccines to deal with emerging variants.
According to Dr. Singh, the mRNA platform they have developed in association with the Department of Biotechnology will enable development of vaccine quickly or any possible variants of concern in future.
Samit Mehta, COO, Gennova Biopharmaceuticals Limited, added that it took them just a few months to develop the Omicron-variant vaccine.
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